Abbott Medical177 County Road B Eastst Paul Mn 55117 Pma Numberp810002 Supplement Numbers116 Date Received12 28 2022 Decision Date01 27 2023 Product Code Lwq Advisory Committee Cardiovascular Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Abbott Medical177 County Road B Eastst Paul Mn 55117 Pma Numberp810002 Supplement Numbers116 Date Received12 28 2022 Decision Date01 27 2023 Product Code Lwq Advisory Committee Cardiovascular Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P810002S116 Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP810002 Supplement NumberS116 Date Received12/28/2022 Decision Date01/27/2023 Product Code LWQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valved Graft with Hemashield™ graft technology (C	2023-01-27